The preservation of the structure and function of biological materials during long-term storage at high temperature and humidity is of fundamental importance to the food, nutraceutical and pharmaceutical industries. Sensitive biological materials, such as proteins, enzymes, cells, bacteria and viruses must often be preserved for long-term storage for later use. Although many methods have been tried for stabilizing biological materials in storage, many are not suitable for sensitive bioactives, such as live or attenuated bacteria and viruses. For example, traditional freeze-drying combines the stresses due to both freezing and drying. The freezing step of this process can have undesirable effects, such as the denaturation of proteins and enzymes, and rupture of cells.
A need exists for a stabilizing composition that is useful for a wide range biological materials and that provides superior stabilization and preservation of biological materials over extended periods of time at elevated temperatures and varying degrees of humidity, such as can be encountered during shipping and storage of materials, while still retaining a significant amount of activity upon rehydration. A need also exists for stabilizing compositions that can be used in tableting applications without excessive loss of activity of biological materials, many of which are sensitive to the high pressures and temperatures encountered during tableting.